The following data is part of a premarket notification filed by American Medical Systems, Inc. with the FDA for Ureteral Stent.
| Device ID | K852389 |
| 510k Number | K852389 |
| Device Name: | URETERAL STENT |
| Classification | Stent, Ureteral |
| Applicant | AMERICAN MEDICAL SYSTEMS, INC. 11001 BREN RD. EAST Minnetonka, MN 55343 |
| Contact | Mark E Mcintyre |
| Correspondent | Mark E Mcintyre AMERICAN MEDICAL SYSTEMS, INC. 11001 BREN RD. EAST Minnetonka, MN 55343 |
| Product Code | FAD |
| CFR Regulation Number | 876.4620 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-06-05 |
| Decision Date | 1985-09-05 |